NCT06327997

An Exploratory Study by Fast CAR T Cells

Exploratory Study on the Treatment of Advanced Solid Tumor With Non-viral Vector Multi-targeted Autosecretory Multifunctional Antibody CAR-T Cell Injection

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Cell Therapy Group Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this trial is to evaluate the safety and tolerability of CAR T cell therapy for advanced solid tumors with positive mesothelin and MUC1.Patients were screened, peripheral blood mononuclear cells (PBMC) were isolated from eligible patients, and cells were prepared. Pretreatment was performed within 5 days before infusion, and CAR T cells were infused on day 0 (the dose was determined according to the requirements of climbing/expansion). The safety intensive observation period was 28 days after infusion, and the clinical efficacy after infusion was evaluated on days 28-34. The follow-up observation and evaluation were carried out according to the follow-up visit point, and the follow-up period was 1 year. From the second year, the telephone follow-up period was entered.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Fast CAR T cells	This study designed three dose groups, each with a dosage of 5.0 × 10\^5/kg、1.0×10\^6/kg、5.0×10\^6/kg

Timeline

• Start date: 2024-03-07
• Primary completion: 2027-03-06
• Completion: 2027-12-31
• First posted: 2024-03-25
• Last updated: 2024-03-25

Locations

1 site across 1 country: China